Method and apparatus for treating pelvic organ prolapse

• US 7,500,945 B2
• Filed: 04/30/2004
• Issued: 03/10/2009
• Est. Priority Date: 04/30/2004
• Status: Active Grant

• Current Assignee: ENDO Operations Limited
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Cox, James E, Lund, Robert E, Watschke, Brian P., Anderson, Kimberly A.
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): Hopkins; Christine D
• Application Number:
  US10/834,943
• Publication Number:
  US 20050245787A1
• Time in Patent Office: 1,775 Days
• Field of Search: 600 29- 30, 600/37, 606/151, 606/185, 623 2364- 2366
• US Class Current: 600/37
• CPC Class Codes: A61B 17/06004 Means for attaching suture to needle tipping A61B17/06195; connecting wire to other metallic objects B21F15/00
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/0042 with special provisions for gripping
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

A method of treating pelvic organ prolapse is provided. The method generally includes the steps of establishing a first pathway between the external perirectal region of the patient to the region of the ischial spine in tissue on one side of the prolapsed organ, followed by establishing a second pathway in tissue on the contralateral side of the prolapsed organ. A support member, which includes a central support portion and two end portions, is positioned in a position to reposition said prolapsed organ in said organ'"'"'s anatomically correct location. The end portions of the support member are introduced through the respective tissue pathways, followed by adjustment of the end portions so that the support member is located in a therapeutic relationship to the prolapsed organ that is to be supported. An apparatus and kit for said treatment is further provided.

Claims

1. A method for repair of pelvic organ prolapse in a patient, said method comprising the steps of:

establishing a first pathway in tissue on a first side of said prolapsed organ, said first pathway extending between an external perirectal region to a region of an ischial spine of the patient;

establishing a second pathway in tissue on a contralateral side of said prolapsed organ, said second pathway extending between an external perirectal region to a region of an ischial spine, and through levator muscle of the patient;

positioning a support member in a position to reposition said prolapsed organ in said organ'"'"'s anatomically correct location, said supporting member comprising a support portion having a first and second end, and two end portions, said end portions respectively attached to said first end and said second end;

introducing said end portions through said first and second pathways, respectively; and

adjusting said end portions so that said support member is in a therapeutic relationship to a tissue of said prolapsed organ that is to be supported.

2. The method of claim 1, wherein said pelvic organ prolapse is a vaginal vault prolapse.

3. The method of claim 1, wherein said pelvic organ prolapse is an enterocele.

4. The method of claim 1, wherein said pelvic organ prolapse is a rectocele.

5. The method of claim 1, wherein said pelvic organ prolapse includes more than one of the group consisting of vaginal vault prolapse, enterocele, and rectocele.

6. The method of claim 2, wherein the step of establishing a first pathway in tissue on a first side of said prolapsed organ, said pathway extending between an external perirectal region to a region of an ischial spine space of the patient, comprises the steps of:

making a midline incision in an apex of a vagina;

dissecting to a region of an ischial spine;

making a first incision lateral and posterior to the rectum in a skin of a buttocks;

passing a needle from said first incision toward said vaginal incision;

palpating a tip of said needle distal and inferior to an ischial spine; and

passing said needle through a levator muscle.

7. The method of claim 2 wherein the step of establishing a second pathway in tissue on a contralateral side of said prolapsed organ, said pathway extending between an external perirectal region to a region of an ischial spine of the patient, comprises the steps of:

making a second incision lateral and posterior to the rectum in a skin of a buttocks on the contralateral side respective to said first incision;

passing a needle from said second incision toward said vaginal incision;

palpating a tip of said needle distal and inferior to an ischial spine; and

passing said needle through a levator muscle.

8. The method of claim 2 wherein said step of positioning a support member in a position to reposition said prolapsed organ in said organ'"'"'s anatomically correct location, said supporting member comprising a support portion having a first and second end, and two end portions, said end portions respectively attached to said first end and said second end, comprises the step of connecting said support member to a tip a needle, said needle being passed from an incision in said patient'"'"'s external perirectal region through a tissue on a side of said prolapsed organ through to said region of an ischial spine of the patient to form said pathway.

9. The method of claim 2, wherein said step of introducing said end portions through said first and second pathways comprises the step of retracting back through said respective pathways a needle to which said end portions have been connected.

10. The method of claim 2, wherein said step of adjusting said end portions so that said support member is in a therapeutic relationship to a tissue of said prolapsed organ that is to be supported further comprises:

attaching said support member to a vaginal wall with sutures;

ensuring a vaginal vault is in an appropriate anatomical position; and

adjusting said support member by manipulation of said end portions.

11. A method of claim 1, wherein the step of establishing a first pathway in tissue on a first side of said prolapsed organ, said first pathway extending between an external perirectal region to a region of an ischial spine space of the patient, comprises:

making an incision in tissue of a vagina;

dissecting to a region of an ischial spine;

making a first incision lateral and posterior to the rectum in a skin of a buttocks;

passing a needle from said first incision toward said vaginal incision;

palpating a tip of said needle distal and inferior to an ischial spine;

passing said needle through a levator muscle;

engaging an end of the needle with a connector located at an end of a first end portion of the supporting member; and

removing the needle to pull the implant portion through the first tissue pathway.

12. The method of claim 11 wherein the first end portion comprises repositioning means.

13. A method of claim 11 wherein the step of establishing a second pathway in tissue on a second side of said prolapsed organ, said second pathway extending between an external perirectal region to a region of an isehial spine space of the patient, comprises:

making an incision in tissue of a vagina;

dissecting to a region of an ischial spine;

making a second incision lateral and posterior to the rectum in a skin of a buttocks;

passing a needle from said second incision toward said vaginal incision;

palpating a tip of said needle distal and inferior to an ischial spine;

passing said needle through a levator muscle;

engaging an end of the needle with a connector located at an end of a second end portion of the supporting member; and

removing the needle to pull the second end portion through the second pathway.

14. The method of claim 13 wherein the first and second end portions each comprise repositioning means.

15. An apparatus for treating pelvic organ prolapse in a patient comprising:

a support portion for placement in a therapeutically effective position, having first and second ends; and

exactly two elongated end portions consisting of

a first elongated end portion connected to said first end of said support portion and configured to extend through a tissue path from vaginal tissue, to a region of an ischial spine, and to an external perirectal incision; and

a second elongated end portion connected to said second end of said support portion and configured to extend through a tissue path from vaginal tissue, to a region of an ischial spine, and to an external perirectal incisions,

wherein the support portion comprises a width and the end portions comprise a width, the widths being perpendicular to the elongate direction of the end portions, the width of the support portion being greater than the width of the end portions, and the support portion extending beyond the width of the end portions in a forward direction and in a rearward direction.

16. The apparatus of claim 15, further comprising a repositioning means to effect tightening or loosening said apparatus without adversely affecting the therapeutic efficacy of said apparatus.

17. The apparatus in claim 16, wherein said repositioning means comprises at least one filament threaded along at least one end portion.

18. The apparatus of claim 16, wherein said repositioning means comprises at least one removable sheath on at least one end portion, said sheath to affect tightening of said apparatus when the apparatus is partially implanted and said sheath is removed.

19. The apparatus of claim 15, wherein said support portion is substantially rectangular, having a first and second long side and two short sides, wherein said first and second end portions are connected to said first and second long sides, respectively.

20. The apparatus of claim 15, wherein said support portion comprises

first and second elongated portions;

and

a means for inserting and securing a biological graft material between said first and second elongated portions.

21. The apparatus of claim 15, wherein said support portion is made from a polypropylene monofilament mesh.

22. The apparatus of claim 15, wherein said support portion is made from a knitted surgical mesh comprised of a knitted yam having a thickness of about 0.021 inches, having about 27.5 courses per inch, and about 13 wales per inch three bar warp knit construction with a bar pattern set-up of#1:

1/0, 2/3, 2/1, 2/3, 1/0, 1/2, 1/0, 1/2 #2;

1/0, 2/3, 2/3, 1/0;

#3;

2/3, 1/0, 1/2, 1/0, 2/3, 2/1, 2/3, 2/1.

23. The apparatus of claim 15, wherein at least one of said end portions is made from a polypropylene monofilament mesh.

24. The apparatus of claim 15, wherein at least one of said end portions is made from a knitted surgical mesh comprised of a knitted yarn having a thickness of about 0.021 inches, having about 27.5 courses per inch, and about 13 wales per inch three bar warp knit construction with a bar pattern set-up of#1:

1/0, 2/3, 2/1, 2/3, 1/0, 1/2, 1/0, 1/2;

#2;

1/0, 2/3, 2/3, 1/0;

#3;

2/3, 1/0, 1/2, 1/0, 2/3, 2/1, 2/3, 2/1.

25. The apparatus of claim 15, wherein said end portions and said support portion are formed from differing mesh knits.

26. The apparatus of claim 15, wherein said end portions and said support portion are formed from differing materials.

27. The apparatus of claim 15, wherein said support portion and said end portions are substantially comprised in a single article, wherein said support portion is wider relative to said end portions.

28. The apparatus of claim 15 wherein at least one of said end portions further comprises a connector configured to attach securely with an end of a needle.

29. The apparatus of claim 18 wherein said removable sheath comprises a plastic sheath, and the apparatus further comprises a connector at an end of each end portion and configured to attach securely with an end of a needle.

30. A kit for repairing pelvic organ prolapse in a patient comprising:

an apparatus as recited in claim 15, wherein the apparatus is an implant, comprising a means for repositioning and supporting said organ in a physiologically correct position; and

a means for attaching said repositioning and supporting means to an appropriate anatomical structure.

31. A kit comprising an apparatus of claim 28 in combination with a needle, the needle comprising an end configured to attach securely to the connector.

32. A kit comprising an apparatus of claim 29 in combination with a needle, the needle comprising an end configured to attach securely to the connector.

33. The apparatus of claim 15 wherein the support portion has comprises a first and second long side and two short sides, wherein the first and second end portions are connected to said first and second long sides, respectively.

34. The apparatus of claim 33 wherein at least one of the end portions further comprises a connector configured to attach securely with an end of a needle.

35. The apparatus of claim 34 further comprising a repositioning means to effect tightening or loosening said apparatus without adversely affecting the therapeutic efficacy of said apparatus.